RUBBER LATEX SURGICAL GLOVES, STERILE— 510(k) K895448

Name: FDA 510(k) clearance K895448
Creator: U.S. Food and Drug Administration
Published: 1989-10-10

Substantially Equivalent

Dah Lee Rubber Industries (Thai) , Ltd.

FDA 510(k) clearance K895448 for RUBBER LATEX SURGICAL GLOVES, STERILE, Substantially Equivalent on 1989-10-10. Applicant: Dah Lee Rubber Industries (Thai) , Ltd.. Device class: 1.

Clearance details

Applicant: Dah Lee Rubber Industries (Thai) , Ltd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1989-09-08
Decision date: 1989-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.